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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to methods resembling OECD guideline 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and a table with results is included.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Vetiver bourbon
IUPAC Name:
Vetiver bourbon
Details on test material:
- Name of test material (as cited in study report): Vetiver Bourbon
- Purity: No data
- Lot/batch No.: Confidential information

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.7-2.7 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: Adbominal area
- Type of wrap if used: 2 single layers of gauze and impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 hours
Duration of exposure:
No data
Doses:
5000 mg/kg
No. of animals per sex per dose:
10 rabbits, unspecified sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs and skin irritation
Statistics:
Not relevant

Results and discussion

Preliminary study:
Not relevant
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Moderate redness and oedema of skin was noted in 10 out of 10 animals
Mortality:
No mortality observed.
Clinical signs:
No effects observed.
Body weight:
No data on weight change reported.
Gross pathology:
Not performed.
Other findings:
- Other observations: moderate redness and edema was noted in 10 out of 10 animals (skin irritation)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, dermal application of Vetiver Bourbon did not induce any mortality at a dose of 5000 mg/kg. Therefore, a LD50 of >5000 mg/kg was established and the substance does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).
Executive summary:

A single dose of 5000 mg/kg test material was applied dermally to the abraded abdominal skin of 10 New Zealand White rabbits. Skin was covered with 2 single layers of gauze and wrapped with impervious material for 24 hours. After 24 hours the wrapping was removed and the rabbits were cleansed. The rabbits were observed for 14 days thereafter for mortality and symptomatology (skin irritation).

Under the conditions of this study, dermal application of Vetiver Bourbon did not induce any mortality or clinical signs at a dose of 5000 mg/kg. Skin irritation was observed, as moderate redness and oedema was recorded in 10 out of 10 test animals. In conclusion, a LD50 of >5000 mg/kg was established and the substance does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).